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Quality Engineer II.US-BOS.006

Integra LifeSciences
South Boston, MA
Closing date
May 18, 2022

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Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we've evolved into one of the world's leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.But that's just the beginning. Integra is growing at an unprecedented rate. We're at a moment in time where the experience you'll gain is more robust than the experience you bring. And we're out to invest in your future because it's the best way to maximize ours. At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra's ongoing commitment to our values and our shared success. Integra's health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both. Regardless of geographic location, our commitment is to offer the following, whenever possible:Benefit plans that meet all local statutory requirementsA range of programs that reflect typical local market practicesAn opportunity for employees to tailor benefits to their specific needsBenefits that balance employee's short-term and long-term needsClick HERE for more information regarding our benefits and total rewards program

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.Assists or leads complaint handling activities (e.g., investigations).Assists or leads in the identification and completion of CAPA activities, including CAPA investigations.Assists or leads Control of Nonconforming Product process activities (e.g., MRB review/approval}.Supports Design Change/Development and Process Changes through team involvement, and thorough review and approval of changes.Develops and implements test method validations as assigned.Reviews and approves validations for new and existing processes and equipment.Identifies and supports Risk Management File updates.Identifies statistically based sampling plans for inspections, verifications and validations.Establishes and maintains Quality Management System procedures related to areas of responsibilities.Ensures compliance with cGMP, QSR, 1S013485, MOD/EU MOR, and other applicable regulations/standards.Participates in FDA inspections, Notified Body audits and customer audits.Collects and reports quality metrics as required.Performs other Quality Engineering related duties as assigned.

Bachelor's degree in Quality Assurance or Engineering or related discipline or 3-5 years of experience in Quality Engineering within the Medical Device Industry.Experience with CAPA processes (e.g., complaints, nonconforming product).Experience with process/test method validations.Knowledge of medical device regulations (including FDA O.SRs, 1S013485).Working knowledge of 0A Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage·; Packaging and Distribution of Product).Technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).Knowledge of statistical sampling and analysis.Ability to communicate effectively (both written and oral) using English (or local language).Familiar with the MS Office Suite, including Microsoft Visio and Project.Must be able to observe company policies and safety procedures at all times.Demonstrated ability to work cross-functionally in a team environment,Certified Quality Engineer (e.g., ASQ CQE) - preferredIn an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.
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